NOTE: The policies, guidelines, terms, and conditions
stated in this announcement may differ from those used by the NIH. Where
this Funding Opportunity Announcement (FOA) provides specific written
guidance that may differ from the general guidance provided in the grant application
form, please follow the instructions given in this FOA. Also note that AHRQ
may have different page limits than NIH for the application Research
Strategy, which can be found within each individual FOA (see Section IV
below). AHRQ Grants Policy and Information to applicants regarding Funding
Opportunity Announcement procedures can be found at Funding Opportunity
Announcement Guidance.

This FOA is a limited competition for AHRQ ARRA-funded
large research grants, specifically awardees currently funded under the:
CHOICE, PROSPECT, Enhanced Registries for Quality Improvement and Comparative
Effectiveness Research, and Scalable Distributed Research Networks for
Comparative Effectiveness Research funding programs. Further details on
these programs can be found below in Part 2, Section I of this FOA.

The goal of this FOA is to extend the usefulness and
further improve the capabilities and patient-centered use of existing
research and/or clinical infrastructure now and in the future. The primary objectives
of the project are to use a stakeholder engagement process to:

1) understand stakeholder needs in order to develop new
comparative effectiveness research questions for which future research could
fill important knowledge gaps and generate critical insights on the clinical
effectiveness and comparative clinical effectiveness of health care
interventions; and

2) enhance the current data
infrastructure and move towards sustainability through developing the ability
to address these additional stakeholder-relevant questions.

Applications must also delineate plans for making the
resources developed in this and the prior ARRA programs more sustainable for
future research and/or clinical funding support.

Key Dates

Posted Date

May 9, 2013

Open Date (Earliest Submission Date)

May 28, 2013

Letter of Intent Due Date(s)

June 7, 2013

Application Due Date(s)

June 28, 2013, by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Generally, four months after receipt date

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date.

Expiration Date

June 29, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions.

Applications that do not comply with these
instructions may be delayed or not accepted for review.

In 2010, AHRQ released several large research grant Funding
Opportunity Announcements (FOAs) supporting comparative effectiveness research
(CER) as part of the American Recovery and Reinvestment Act (ARRA) CER
investment. These FOAs were:

The grant programs noted above represented large investments
aimed at answering pressing CER questions and developing infrastructure that
could be used for CER and PCOR. Notwithstanding the success of these programs,
AHRQ recognizes that the 3 year time-frame of these awards limits the full
benefits of the research investments that have been made as well as the type
and intensity of stakeholder engagement needed to fully develop the potential
of the data infrastructure. The purpose of this FOA is to conduct of a limited
competition to increase the capacity and impact of the projects funded under the
FOA's listed above, to improve the opportunities for sustainability of the
resources these projects funded represent by improving responsiveness to
stakeholders, to further promote the use of patient-centered outcomes in CER
and PCOR, and to provide infrastructure for future research aimed at enhancing
real-world decision making. The immediate goals are to enhance the data
resources and relevant analytic methods and to enhance the stakeholder
engagement in order to understand their needs that can be met by the
infrastructure. Examples of these needs may be stakeholder-relevant research
questions that improve patient decision making and shared decision-making,
improve workflow and health care practices, and/or address issues of interest
to policymakers. This FOA provides for the development of CER/PCOR
infrastructure and not the conduct of research, but the new development of
infrastructure should be guided by specific, stakeholder-driven research
questions to insure the utility of the resources developed. The ultimate goal
of this FOA is to develop a comprehensive and sustainable data infrastructure
that has capability and flexibility to address a range of current and future
stakeholder needs related to CER and PCOR. Current recipient organizations
funded under the above FOAs are eligible to apply for the current FOA. The
PD/PI of the proposed project may be the current PD/PI of the grant funded
under the above FOAs or be a qualified individual from the applicant
organization endorsed by the current PD/PI.

Projects resulting from the four FOAs noted above involved
developing research infrastructure, whether for recruiting participants into a
clinical trial, a condition oriented registry, or a linkage of clinical data
systems. The projects were also designed to use this infrastructure to answer
relevant and targeted questions centered around comparative effectiveness. In
the current FOA, we request applications that enhance the capability and extend
the usefulness of the research and/or clinical infrastructure to improve the
ability to address new questions in comparative effectiveness or PCOR. For the
purpose of the current FOA, examples of applicable infrastructure include
research databases and data structures, linkages across data sets within and
across diverse organizations, mechanisms for enhanced patient recruitment, and patient-reported
outcome data. This FOA aims to enhance all or part the infrastructure
developed from the original investments to improve the capacity for new comparative
effectiveness research or PCOR to meet the relevant needs of diverse
stakeholders. An explicit and comprehensive approach is needed to understand
stakeholder needs. In order to understand the capability of the data
infrastructure to meet stakeholder needs, new, stakeholder-relevant questions
should be developed and the capability of the network to address these
questions should be evaluated.

To collect additional data to supplement the current data
infrastructure. These additional data could comprise additional collection of
new data elements for current study participants and/or recruit additional
participants to fulfill a need specifically identified by a stakeholder, e.g.
to evaluate heterogeneity or expand findings in an underrepresented subgroup
for which the study is currently underpowered. Since the FOA covers
infrastructure and not research, data collection to enhance infrastucture for
future research to address research questions is allowable, but the FOA does
not cover research to evaluate the questions.

To collect longer-term follow-up data on current participants to
ascertain the impact of CER interventions on meaningful patient–centered
outcomes. Additional longitudinal data may overcome the limitation of
analysis of short duration outcomes imposed by the limited time-frame of the
original studies, should potential users of these data for decision making
require longer-term outcomes.

To validate newly created research tools and software for CER or
PCOR in different patient populations and/or extend the applicability of these
tools to new populations.

2.Enhance stakeholder
engagement to understand their needs. To enhance stakeholder
engagement, the applicants could add to diversity and number of existing stakeholders,
increase intensity of engagement and explicitly ask questions to better
understand their needs. This is necessary to move the data infrastructure to a
model that moves towards economic sustainability of the research infrastructure
by being useful for clinical practice and/or quality improvement. Expanding the
multi-functional capability of the infrastructure to meet the needs of diverse
stakeholders will support long-term stakeholder participation and the ultimate
sustainability of the infrastructure. The infrastructure capability to address
research questions includes clinical effectiveness and comparative clinical
effectiveness of health care interventions for prognostic, preventive,
diagnostic, therapeutic, or palliative purposes, and the interventions could
include drugs, devices, surgical procedures, behavioral, or health system
interventions

3. Assess
the capability of the data infrastructure to meet stakeholder needs.
The resources for this FOA will not allow for the conduct of a research
study. Applications that propose the conduct of research will not undergo peer
review or be considered for funding. However, pilot projects to test the
completeness and accuracy of the infrastructure in order to ascertain the validity
of the infrastructure will be helpful in evaluating and planning for future use
and development of the infrastructure as a resource for CER or PCOR to meet
stakeholder needs. The pilot study will not be a research study, i.e. the aim
of the pilot study is to evaluate the capability of the resources for conduct
of future research to answer the relevant research questions guiding
infrastructure development rather than to answer these research questions. In
order to test that capability, it is important to know whether the
infrastructure can collect or is collecting relevant and valid data. Examples
of evaluating the capability of the infrastructure include, but are not limited
to evaluation of: the diverse patient subgroups that are included in the network;
the linkages between different databases (e.g. diagnostic, pharmacy, claims,
EHRs); the ease of extracting information from these databases; the
completeness and accuracy of the data elements; the analytic and clinical
utility of the data elements; the details on the clinical interventions
available in the infrastructure (e.g. the types of devices used in procedures
or the types of patient-reported outcomes collected); and the governance and
policy structures established to comply with relevant regulations. Applicants should
not budget more than 20% of total grant funds for the pilot projects.

Applications that address development of infrastructure in
the absence of improved stakeholder engagement or assessing the capability to
answer an explicit and relevant research question will be deemed non-responsive
and will not undergo review. The conduct of the proposed project should guide
the opportunities to improve the chance for sustainability of the current
research infrastructure. Thus, as part of the project plan, the application
must delineate a process to enhance the sustainability of the resource. This
process could consider, for future research purposes, issues such as
maintenance of the research infrastructure (including personnel and data
repositories), establishing or maintaining data linkages and data
infrastructure, researcher access to and interface with data resources, and
data reporting.

Sustainability maximizes the value of the investment in the original
research projects. For the purposes of this FOA, AHRQ takes a broad approach
to evaluating sustainability; this could include improving either the research
network aspects or the data aspects of the research resource, e.g.,
strengthening the data quality of current elements or expanding the breadth of
data collection to meet stakeholder needs, so that the project increases the
likelihood of future research and/or clinical funding for the infrastructure,
or enhancing the capacity to accrue priority populations under-represented in
trials for future research studies. For those projects that do not expect to
continue new participant accrual, sustainability of the resource could be
enhanced by additional data collection on current participants to enhance
relevance of the data resource for future research, or through the evaluation
of data linkages to extend the relevance of the project data. The aim of the
efforts towards sustainability would be to increase the relevance and
prominence of infrastructure to move towards a truly exceptional resource as
part of the project, whether this development is aimed at future research
funding or future funding by clinical health systems.

The application must also describe plans for governance of
the infrastructure project (see Section IV.2 below). Governance includes data
governance and network governance. Data governance deals with issues and
policies related to data security and access in order to comply with applicable
regulations and also to protect the privacy and confidentiality of a patient’s
information as well as proprietary information of an organization.
Network governance involves a framework for stakeholder engagement and
active involvement in shaping the infrastructure development, as well as
policies to manage organizational partnerships, collaborations, and
coordination of research activities. It may included policies, personnel,
and interventions to enhance recruitment of under-represented populations (when
applicable). It also includes policies to manage conflicts of interest.

AHRQ expects that applications submitted under this FOA
will:

Have significant stakeholder input into the project. As part of
this application, the applicants should propose relevant stakeholders that they
will meaningfully engage during appropriate stages of the project. Examples of
engagement would include input on refining and finalizing the protocol,
especially to identify relevant outcomes, and assistance with developing plans
for dissemination of the availability of the research resources and the
willingness to disseminate future research findings. In addition to
identifying stakeholders for the application, applicants must plan on and
budget for at least one face-to-face meeting with their stakeholders, and
demonstrate plans for ongoing engagement during the project.

Develop infrastructure informative for a real-world clinical
decision for which new knowledge would help the public, patients, clinicians,
or policy makers make better decisions.

Be grounded in sound scientific methodology and informed by prior
research.

Have an explicit plan on governance and sustainability of the
infrastructure.

In addition, AHRQ expects successful
applicants to participate in and collaborate with other successful applicants
and relevant experts through the Electronic Data Methods (EDM) Forum. The EDM
Forum is an AHRQ-supported mechanism to convene investigators, technical
experts and diverse stakeholders interested in using electronic data
infrastructure for CER, PCOR, QI, and support of clinical care. Along with
AHRQ’s Office of Communications and Knowledge Transfer, the EDM Forum also
provides several dissemination opportunities relevant to these projects, including
project snapshots posted on its website; publication of protocols, conceptual
frameworks, case studies through eGEMS (an electronic, peer-reviewed
publication); webinars and similar web-based dissemination activities. Investigators
are expected to attend steering committee meetings (for planning purposes,
assume two investigators traveling to steering committee meetings a total of
three times over the duration of the grant). As part of this participation, applicants
should propose plans to conduct one webinar for the EDM forum to occur during
the duration of the grant. Details on the EDM Forum are available at: www.edm-forum.org .

Section II. Award Information

Funding Instrument

Grant

Application Types Allowed

New

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

AHRQ intends to commit $4.8
million in FY 2013 and fund up to 7 awards. The number of awards is
contingent upon AHRQ appropriations and the submission of a sufficient number
of meritorious applications. AHRQ may add additional funds and fund
additional awards should further funds become available.

Award Budget

Application budgets are limited to total costs (including
direct and indirect costs) of $750,000 for the proposed project period.

Award Project Period

The proposed project period must not exceed 18 months.

These projects are being funded pursuant to 42 U.S.C. 299a,
which provides that AHRQ shall conduct and support research, support
demonstration projects, and disseminate information on health care and on
systems for the delivery of such care, including activities with respect to the
quality, effectiveness, efficiency, appropriateness, and value of health care
services.

This FOA is a limited competition. The goal of this FOA is
to extend the usefulness of research and clinical infrastructure developed
within the four grant programs listed in Section I to answer new research
questions in comparative effectiveness. Thus, only those primary recipient institutions
that currently hold grants funded under one of the four FOAs listed above in Section
I are eligible to apply. Institutions having multiple current awards funded
under the FOAs listed above in Section 2, Part I may submit one application for
each current award.

AHRQ’s authorizing legislation does not allow for-profit
organizations to be eligible to lead applications under this research mechanism,
thus for-profit organizations may participate in projects as members of
consortia or as subcontractors only. Because the purpose of this program is to
improve healthcare in the United States, foreign institutions may participate
in projects as members of consortia or as subcontractors only.
Applications submitted by for-profit organizations or foreign institutions will
not be reviewed. Organizations described in section 501(c) 4 of the
Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform
a substantive role in the conduct of the planned project or program activity
and not merely serve as a conduit of funds to another party or parties. If
consortium/contractual activities represent a significant portion of the
overall project, the applicant must justify why the applicant organization,
rather than the party(s) performing this portion of the overall project, should
be the grantee and what substantive role the applicant organization will play.
Justification can be provided in the Specific Aims or Research Strategy section
of the PHS398 Research Plan Component sections of the SF424 (R&R) application.
There is no budget allocation guideline for determining substantial
involvement; determination of substantial involvement is based on a review of
the primary project activities for which grant support is provided and the
organization(s) that will be performing those activities.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

For the current FOA, the PD/PI is limited to the current
PD/PI of a project funded through one of the four FOAs listed in Section 2,
Part I, or a qualified individual from the applicant institution who is endorsed
by the current PD/PI. The skills, knowledge, and resources to carry out
the proposed research should be well justified in the application. If the
PD/PI is not the original PD/PI, the Appendix must contain a letter of support
from the original PD/PI or the Dean or Business Officer of the eligible
institution describing the relationship of the proposed PD/PI to the original
research study, and his/her qualifications for and commitment to the completion
of the proposed work. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for AHRQ support.

2. Cost
Sharing

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this
FOA, AHRQ welcomes applicant institutions, including any collaborating
institutions, to devote resources to this effort. An indication of
institutional support from the applicant and its collaborators indicates a
greater potential of success and sustainability of the project. Examples of
institutional support would include: donated equipment and space, institutional
funded staff time and effort, or other resource investments. Applicant
institutions should indicate institutional support by outlining the specific
contributions to the project and providing assurances that their organization
and any collaborators are committed to providing these funds and resources to
the project. This information can be included at the end of the budget
justification section of the application, but institutional support dollars are
not to be shown/included in the detailed budget request.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by
having a unique DUNS number) per current awardee is allowed. Institutions
having multiple current awards funded under the FOAs listed above in Section 2,
Part I may submit one application for each current award.

AHRQ will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months, except for
submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows AHRQ staff to estimate the potential review workload
and plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of Page
Limits must be followed,

PHS 398 Research Plan Component

All application instructions outlined in the SF424 (R&R)
Application Guide that
are not otherwise specified within this Funding Opportunity Announcement must be followed, incorporating "Just-in-Time" information concepts,
and with the following additional requirements:

Introduction is limited to 1 page.

Specific Aims is limited to 1 page.

Research Strategy, including tables, graphs, figures,
diagrams, and charts, is limited to 12
pages.

Budget
Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award
Process. Applicants for funding from AHRQ should ignore application
instructions concerning the Modular Grant Application and Award Process, and
prepare applications using instructions for the Research and Related Budget
Components of the SF 424 (R&R). Applications submitted in the Modular
format will not be reviewed.

In the PHS 398 Research Plan Component, the following two
additional sections must be included after the Research Strategy section (and
do not count against the 12 page limit stated above for the Research Strategy
Section).

Infrastructure
Governance. Applicants must describe the research
infrastructure resources used in the proposed project, including plans for
maintaining and governing the resources. Consideration of both network
governance and data governance should be presented. Stakeholder engagement should
be included as part of this section, including identification of stakeholders,
a description of the relevance of the stakeholders to the research and/or
sustainability of the infrastructure, and specific plans on timeline and
content of how the investigators plan to engage the stakeholders as part of
this project. This section is limited to 3 pages.

EDM
Forum Webinar. As part of the EDM forum participation, applicants
must propose 1-2 topics for a webinar to be conducted with the EDM forum. This
webinar would be conducted by the investigators, and could address issues such
as content of the infrastructure project, lessons learned in the development or
governance of the research resources, plans for sustainability of the resource,
innovative methods for stakeholder engagement, or other areas that would be of
interest to a network of researchers interested in comparative effectiveness
research in large data resources. For budget purposes, the applicants should
assume that they would be responsible for one 2-hour webinar, which they would
host for 100 participants. This section is limited to 1 page.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide, with the following modification:

If the proposed PD/PI is not the current PD/PI of the current
award, the application must include an appendix including a letter addressing
the qualifications of this individual. See the section above on Eligible
Individuals (Program Director/Principal Investigator) for more information.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application corrections
that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the deadline in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For efficient grant administration, AHRQ grant
administration procedures will be used and conducted in accordance with the
terms and conditions, cost principles, and other considerations described in
the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A grantee may, at its own
risk and without AHRQ prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs are necessary to conduct the project and
would be allowable under the grant, if awarded, without AHRQ prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain AHRQ approval before incurring the cost. AHRQ prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.

6. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:The PD/PI must include his/her eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for theSystem for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH, and for responsiveness by
AHRQ. Applications that are incomplete and/or nonresponsive will not be
reviewed.

In order to expedite the review, applicants are requested to
notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and
title, PD/PI name, and title of the application.

Institutional Review Board (IRB) approval of human subjects
is not required prior to peer review of an application (see
https://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However,
initiation of IRB review, if necessary or applicable, is strongly encouraged to
assure timely commencement of research.

Although there is no immediate acknowledgement of the
receipt of an application, applicants are generally notified of the review and
funding assignment within eight (8) weeks.

Priority
Populations

AHRQ
supports research, evaluations, and demonstration projects concerning the
delivery of health care in inner-city and rural areas (including frontier
areas), and health care for priority populations. Priority populations include
low income groups; minority groups; women; children; the elderly; and
individuals with special health care needs, including individuals with
disabilities and individuals who need chronic care or end-of-life health care.
42 USC 299(c). Women and members of minority groups are included in all
AHRQ-supported research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate, e.g. because of the lack of connection between the study and the
health of women or particular minorities. Investigators should review the document
entitled, “AHRQ Policy on the Inclusion of Priority Populations,” which is
available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html.
Applicants under this FOA should consider and discuss including priority
populations in the research design as specified in this Notice.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning to
share the data. Applicants who are planning to share data may wish to describe
briefly the expected schedule for data sharing; the format of the final
dataset; the documentation to be provided; whether or not any analytic tools
also will be provided; whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use); and the mode of data sharing (e.g., under its own
auspices by mailing a disk or posting data on its institutional or personal
website or through a data archive or enclave). Investigators choosing to share
under their own auspices may wish to enter into a data-sharing agreement.
References to data sharing may also be appropriate in other sections of the
application.

The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires
that information that is obtained in the course of AHRQ supported activities
and that identifies individuals or establishments be used only for the purpose
for which it was supplied. Information that is obtained in the course of
AHRQ-supported activities and that identifies an individual may be published or
released only with the consent of the individual who supplied the information
or is described in it. There are civil monetary penalties for violation of the
confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human
Subjects section of the application, applicants must describe procedures for
ensuring the confidentiality of the identifying information to be collected.
The description of the procedures should include a discussion of who will be
permitted access to this information, both raw data and machine readable files,
and how personal identifiers and other identifying or identifiable data will be
restricted and safeguarded. Identifiable patient health information collected
by grantees under this FOA will also be obtained and managed in accordance with
the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee should ensure that computer systems containing
confidential data have a level and scope of security that equals or exceeds
that established by the HIPAA Security Rules if applicable (see HIPAA website
in prior paragraph) and that established by the Office of Management and Budget
(OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated
Information Systems. The applicability and intended means of applying these
confidentiality and security standards to subcontractors and vendors, if any,
should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may
copyright, or seek patents for, as appropriate, final and interim products and
materials developed in whole or in part with AHRQ support, including, but not
limited to, methodological tools, measures, software with documentation,
literature searches, and analyses. Such copyrights and patents are subject to
a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce,
publish, use or disseminate for any purpose consistent with AHRQ’s statutory
responsibilities and to authorize others to do so for any purpose consistent
with AHRQ’s statutory responsibilities. In accordance with its legislative
dissemination mandate, AHRQ purposes may include, subject to statutory
confidentiality protections, making project materials, databases, results, and
algorithms available for verification or replication by other researchers. In
addition, subject to AHRQ budget constraints, final products may be made
available to the health care community and the public by AHRQ or its agents if
such distribution would significantly increase access to a product and thereby
produce substantial or valuable public health benefits. Ordinarily, to
accomplish distribution, AHRQ publicizes research findings but relies on
grantees to publish research results in peer-reviewed journals and to market
grant-supported products. AHRQ's Office of Communications and Knowledge
Transfer (OCKT) wishes to be consulted in advance of publication in order to
coordinate announcements of new AHRQ-supported research results with other AHRQ
dissemination activities. Important legal rights and requirements applicable
to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42
CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html)
which incorporates additional applicable provisions on Rights in Data,
including 45 CFR Part 74 and 37 CFR Part 401.

Grantees will retain custody of and have primary rights to
the data and software developed under these awards, subject to Government
rights of access consistent with current DHHS, PHS, and AHRQ policies.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.:

The mission of AHRQ is to improve the quality, safety,
efficiency, and effectiveness of health care for all Americans. As part of this
mission, applications submitted to AHRQ to support health services research are
evaluated for scientific and technical merit through the AHRQ peer review
system.

Applications that are complete and responsive to the FOA
will be evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with standard AHRQ peer review procedures
that are described in 42 CFR Part 67, Subpart A. Incomplete and/or
non-responsive applications or applications not following instructions given in
this FOA will not be reviewed.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit will be discussed and
assigned a priority score

Receive a written critique

Administrative Criteria: Upon receipt, applications will be
evaluated for completeness by the Center for Scientific Review, NIH, and for
responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described
below, will be considered in the review process.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field? Does the proposed infrastructure development address clinical
effectiveness and comparative effectiveness of health care interventions? Has a
research question guiding infrastructure development been identified as a need
by a stakeholder? Will the proposed infrastructure development clearly address
the identified need?

Investigator(s)

Are the PD/PI, collaborators, and other researchers appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the PD/PI and other researchers? Do the
PD/PI and investigative team bring complementary and integrated expertise to
the project (if applicable)? Is the leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Is the project original and innovative? For example:
Does the project challenge current research or seek to shift clinical practice
paradigms; address an innovative hypothesis or critical barrier to progress in
the field? Does the project develop or employ novel concepts, approaches or
methodologies, tools, or technologies for this area? Is the approach to meeting stakeholder evidentiary needs and/or the approach to enhancing the infrastructure
innovative? Does the topic(s) proposed for the EDM forum webinar represent an
innovative contribution to knowledge and experience about electronic data
infrastructure?

Approach

Are the conceptual or clinical framework, design,
methods, and analyses adequately developed, well-integrated, well-reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative strategies? Are benchmarks for
success presented? If the project is in the early stages of development, will
the strategy establish feasibility and will particularly risky aspects be
managed? Does the applicant provide an adequately developed plan to enhance the
sustainability of the infrastructure? Are the plans for network governance and
data governance adequate for the questions and proposed use of the established
resources?

Environment

Do(es) the scientific environment(s) in which the
work will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment(s), or
subject populations, or employ useful collaborative arrangements? Is there
evidence of institutional support?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Degree of Responsiveness

Reviewers will assess how well the application
addresses the purpose and objectives of this FOA. How responsive is the
application to the special eligibility criteria, including the project
requirements, noted in the FOA? [Does the applicant provide a clear plan for
data governance and network governance for the research resources? Has a plan
for engaging relevant stakeholders been adequately detailed? Has the applicant
provided an adequate and innovative plan for a webinar or webinars to be
presented through the EDM forum? ]

Inclusion of Priority Populations

Reviewers will assess the adequacy of plans to
address the needs of both genders, racial and ethnic minorities (and
subgroups). Adequacy of attention to AHRQ priority populations (see above
discussion on Priority Populations in section IV.6 “Other Submission
Requirements”).

Budget and Period of Support

The committee will evaluate whether the proposed
budget is reasonable and whether the requested period of support is appropriate
in relation to the proposed research. [

Privacy and Security Protections for
Patients

Reviewers will assess the resources and processes to
be used to address privacy and security issues in the development and implementation
of the intervention.

Additional Review Considerations

Not Applicable

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review
Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications
will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding
decisions:

Scientific and technical merit of the proposed project as
determined by peer review.

Availability of funds.

Responsiveness to goals and objectives of the FOA.

Relevance and fit within AHRQ portfolio priorities, as well as
overall programmatic balance.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, AHRQ
will request "Just-In-Time" information from the applicant.
Just-In-Time information generally consists of information on other support,
any additional information necessary to address administrative issues, and
certification of IRB approval of the project's proposed use of human
subjects. For details, applicants may refer to the "AHRQ Revised
Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols
in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization for successful applications. The NoA signed by the AHRQ grants
management officer is the authorizing document and will be sent via email to the
grantee’s business official.

Selection of an application for award is not an authorization to begin performance.
Any costs incurred before receipt of the NOA are at the recipient’s risk.
These costs may be reimbursed only to the extent considered allowable pre-award
costs. See also Section IV.5., “Funding
Restrictions.”

All AHRQ grant and cooperative agreement awards are subject
to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants
Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm),
and the terms and conditions set forth in the notice of grant award.

As necessary, additional Terms and Conditions will be
incorporated into the award statement.

The annual progress reports must include Sections 2.2.6 A
through F as described in the general PHS form 2590 instructions. For details
regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.
If instructions on the AHRQ website are different from the PHS form 2590
instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative
comments on both completed activities and plans for the remainder of that year,
including any changes foreseen in the future. At a minimum, the reports
will include descriptive comments on: progress to date measured against
project aims; methodological changes implemented; key preliminary findings;
significant problems and resolutions; inclusion of priority populations; and
project related publications, presentations, and dissemination
activities. AHRQ will provide the timetable for these progress reports.
In addition to the annual progress report, recipients may be required to submit
quarterly progress reports to AHRQ. Detailed instructions on reporting
requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial
Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for
ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).
AHRQ implementation of the FFR retains a financial reporting period that
coincides with the budget period of a particular project. However, the
due date for annual FFRs will be 90 days after the end of the calendar quarter
in which the budget period ends. Note that this is a change in due dates
of annual FFRs and may provide up to 60 additional days to report, depending
upon when the budget period end date falls within a calendar quarter. For
example, if the budget period ends 4/30/2014, the annual FFR is due 9/30/2014 (90
days after the end of the calendar quarter of 6/30/2014).

A final Progress Report, final Federal Financial Report, and
Final Invention Statement are required when an award ends. For further details
regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section
VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Direct your questions about
general FOA issues, including information on the inclusion of priority
populations to CERDataResourcesFOA@ahrq.hhs.gov . For reasons of equity and consistency, all
scientific/research (program related) inquiries pertaining to general FOA
issues must be submitted, and will only be answered, via email. A compilation
of frequently asked questions and answers will be posted at: http://www.ahrq.gov/fund/grantix.htm.

Recently issued AHRQ policy notices may affect your
application submission. A full list of policy notices published by AHRQ is
provided in the NIH
Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the HHS
Grants Policy Statement.

This program is described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is
not subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review. Awards are made under the authority of
42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74
or 92 and other referenced applicable statutes and regulations. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants Policy Statement. The HHS Grants
Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.